On February 3, 2022, ICER released its draft evidence report, “Special Assessment of Outpatient Treatments for COVID-19.” This is the most recent step in ICER’s process that is expected to conclude with a public meeting in April and the release of a final report in May.
When the pandemic started in 2020, the focus was on finding vaccines for COVID-19 that safely and effectively protected people against serious illness and death. In the U.S. there are three vaccines available, but unfortunately, only about 65% of the U.S. population has been “fully vaccinated” (75% of adults), and new variants continue to develop – in large part because of the large global pool of unvaccinated people.
The good news is that treatments for people with COVID-19 have been developed. The first of those were existing medicines that could be used for people with more advanced COVID-19 – particularly in the hospital. Since then, additional treatments – including newly developed medicines – have been made available for people with mild-to-moderate COVID-19. Initial research looked at the effectiveness of those treatments in unvaccinated people who had risk factors for developing serious COVID-19. ICER’s draft “Special Assessment” evidence report focuses on that population.
While recognizing the highly unusual nature of the COVID-19 pandemic, ICER is essentially using its normal process and timeline for developing and producing a final report. This “normal” process is problematic because COVID-19 treatment options and recommendations are changing rapidly. For example, one of the medicines ICER identified for the report had its authorization for treating COVID-19 withdrawn by the FDA because of it being ineffective against the Omicron variant, and another receiving authorization for outpatient use after ICER published its “research protocol” in November. Those two examples illustrate the problems with ICER’s prolonged process and timeline. In contrast, the NIH’s COVID-19 Treatment Guidelines are updated very frequently.
Out of necessity, ICER modified its analytical criteria for this special assessment because peer reviewed published data is not available for one of the medicines that the FDA has authorized, so ICER cites the company’s press release and related materials – which is something ICER would not do in its “normal” process.
Three of the four treatment options ICER included in the draft report have received authorization from the FDA, while the fourth (generic fluvoxamine) is still being researched. The overall effectiveness and a prioritized recommendations for those three medicines (and remdesivir) are in the National Institutes of Health’s COVID-19 Treatment Guidelines for choosing treatment options for people with mild-to-moderate COVID-19 who are not hospitalized and at high risk for more serious illness: (See Figure below – Note: NIH updated the recommendations for patients not in a hospital with mild-moderate COVID-19 on January 19, 2022, but the summary information has not changed.)
From 1/26/2022 presentation by Dr. Gulick at APHA/NAM “Covid-19 Conversations” session: https://www.covid19conversations.org/Webinars/third-year.
An additional clinical benefit of these treatment is that they should ease the strain on healthcare systems and clinicians that – in some situations because of too many people with COVID-19 – had to stop admitting patients and canceled “elective” activities like some surgeries and cancer treatments. That is, the availability of new treatments for unvaccinated people who have mild-to-moderate COVID-19 will help everyone – including vaccinated people – have better access to needed healthcare services.
In its report, ICER found that all four treatments were cost-effective. Not surprisingly, the generic medicine fluvoxamine was the most cost-effective because it has such a low per treatment cost. However, it has also not been authorized by the FDA for treating COVID-19. And, its clinical trials have mostly occurred outside the U.S. and were based upon different criteria and metrics than the other treatments. Also, ICER did not evaluate the cost-effectiveness of remdesivir in this report, but it may do so in the revised report scheduled for release at the end of March.
Despite the unprecedented situation of the COVID-19 pandemic, ICER based its cost effectiveness analysis on the Quality Adjusted Life Year (QALY), a metric that has been widely criticized because, among other problems, it discriminates against people with chronic conditions and disabilities, including some that put people at higher risk for severe COVID-19.
In evaluating the four treatment options based upon their ability to improve QALYs and then the cost per increase in QALYs, ICER found that the medicines had different but relatively good cost-effectiveness:
From ICER “Special Assessment of Outpatient Treatments for COVID-19,” 2/3/22, p. 30.
It is uncertain how ICER will modify their calculations in the next version of the report since there will certainly be more information available. In particular, it is possible that ICER will extend the scope of the report to evaluate the use of these (and other) treatments in vaccinated people and individuals who are not at high risk for serious COVID-19 since there is ongoing research for use of at least one of the treatments (Paxalovid) in that population. ICER could find that the use of some treatments would not be cost effective in some vaccinated individuals, such as younger people who do not have risk factors – although it is unclear if ICER would consider if those people work or live with anyone who has high risk conditions.
Further, it is expected that additional treatment options – including possible combination treatments with existing and yet to be developed medicines – will refine the treatment paradigm, and hence what ICER (and others) could calculate for cost-effectiveness.
The different options for treating mild-to-moderate COVID-19 for people outside hospitals is very reassuring since it has only been two years since the pandemic began, so having four (and possibly more) new medicines is quite remarkable. Along with vaccines – which unfortunately haven’t been taken by enough people in the U.S. to effectively squelch the virus’ spread – clinicians now have a wider array of options for keeping people healthy.
Those medicines should also ease the burden on clinicians and hospitals so that they can provide care for everyone who needs it, and not have to limit or cancel elective or not emergency surgeries and treatments.
The biggest challenge going forward will be to continue convincing people who haven’t been vaccinated to get their shots, making sure people who have been vaccinated are “up to date” (whether that means with a so-called “booster” shot, or with modified vaccines specific to variants of concern), enabling public health professionals to continue promoting appropriate masking practices (depending on the situation and community rate of viral spread), providing easy access to testing and treatments, and encouraging other “normal” adult and pediatric vaccines.
In addition, so as to not let people think that they can rely on effective treatments in lieu of vaccinations, healthcare, businesses, and community leaders may be providing incentives for vaccinations – ranging from requirements for vaccinations before certain activities (such as workplaces, museums, restaurants etc.), as well as potentially higher health insurance premiums for people who are not vaccinated, which will contrast with the vaccines continuing to be free for patients after the public health emergency and federal purchasing of vaccines ends.